Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma

Cedars-Sinai Medical Center31 enrolled

Overview

This pilot study of scalp cooling with Penguin cold caps will examine the effectiveness of scalp cooling to reduce the development of hair loss in 30 participants with multiple myeloma undergoing high-dose chemotherapy with melphalan and autologous peripheral blood stem cell transplant at Cedars-Sinai Medical Center. The investigators will also assess the potential impact of hair loss versus the discomfort and inconvenience of the scalp cooling procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

Penguin Cold CapDEVICE

Penguin cold cap: administered 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * ECOG performance status ≤2 * Confirmed multiple myeloma diagnosis * Hair covering ≥75% of scalp on physical exam at screening visit * Planning to undergo SOC high-dose chemotherapy with melphalan (dose to be used = 140 - 200 mg/m2 (with rounding per CSMC guidelines)) followed by an autologous peripheral blood stem cell transplant. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Prior or current use of any scalp cooling treatment * Hair covering \< 75% of the scalp on physical exam at screening visit. * Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia * Current spinal or neck injury that may interfere with the subject's participation for the full duration of the study, in the opinion of the treating investigator * Skin conditions such as psoriasis, eczema, malignancy, or other condition on the scalp that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Current use of oxaliplatin * Current use of any other investigational agents * Contraindication to melphalan

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Change in Development of Hair Loss

Change in development of hair loss will be defined as \< 50% hair loss (according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5, Grade 0 or 1) in 75% of patients treated. In CTCAE (Common Terminology Criteria for Adverse Events) version 5.0, alopecia is graded based on the extent of hair loss, with two main grades: Grade 1 (hair loss less than 50%, not obvious from a distance) and Grade 2 (hair loss of 50% or more, readily apparent). Grade 1 alopecia may be manageable with different hairstyles, while Grade 2 typically requires a wig or other camouflage if desired. Additionally, Grade 2 alopecia is more likely to impact a patient's quality of life. Grade 0 indicates that there is no alopecia (no hair loss) reported

Time frame: Screening (Day 0), Day 30

Secondary Outcomes

Patient Determined Decision of Scalp Cooling Benefit

Patient determined decision of scalp cooling benefit will be measured by Scalp Cooling Questionnaire, a homegrown scale ranging from no benefit to substantial benefit, with higher scores representing a better outcome.

Time frame: Day 90

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.